U.S. patent application number 15/775256 was filed with the patent office on 2018-12-13 for intermaxillary fixation device and method of using same.
The applicant listed for this patent is AUTONETWORKS TECHNOOGIES, LTD., SUMMITOMO ELECTRIC INDUSTRIES, LTD., SUMMITOMO WIRING SYSTEMS, LTD.. Invention is credited to Jeffrey R. Marcus.
Application Number | 20180353230 15/775256 |
Document ID | / |
Family ID | 58695546 |
Filed Date | 2018-12-13 |
United States Patent
Application |
20180353230 |
Kind Code |
A1 |
Marcus; Jeffrey R. |
December 13, 2018 |
INTERMAXILLARY FIXATION DEVICE AND METHOD OF USING SAME
Abstract
A method for fixating or stabilizing a subject's mandible and
maxilla includes providing multiple bone fasteners, providing two
arch bars, attaching a first grouping of the bone fasteners to the
subject's mandible, then securing the first arch bar to the first
grouping of bone fasteners, attaching a second grouping of the bone
fasteners to the subject's maxilla, then securing the second arch
bar to the second grouping of bone fasteners, and then fastening
the first arch bar to the second arch bar.
Inventors: |
Marcus; Jeffrey R.; (Chapel
Hill, NC) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
AUTONETWORKS TECHNOOGIES, LTD.
SUMMITOMO WIRING SYSTEMS, LTD.
SUMMITOMO ELECTRIC INDUSTRIES, LTD. |
Yokkaichi-shi. Mie
Yokkaichi-shi, Mie
Osaka-shi, Osaka |
|
JP
JP
JP |
|
|
Family ID: |
58695546 |
Appl. No.: |
15/775256 |
Filed: |
November 11, 2016 |
PCT Filed: |
November 11, 2016 |
PCT NO: |
PCT/US2016/061525 |
371 Date: |
May 10, 2018 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
62253802 |
Nov 11, 2015 |
|
|
|
62319691 |
Apr 7, 2016 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/8071 20130101;
A61C 7/20 20130101; A61C 7/36 20130101; A61C 8/0096 20130101 |
International
Class: |
A61B 17/80 20060101
A61B017/80; A61C 8/00 20060101 A61C008/00; A61C 7/36 20060101
A61C007/36 |
Claims
1. A medical apparatus comprising: a plurality of bone fasteners
configured for attachment to a mandible, a maxilla, a bone graft
thereof, or a prosthodontic jaw portion of the subject, each bone
fastener comprising: a head having an upper portion separated from
a lower portion by a groove, and a shaft extending from the lower
portion; a prosthedontic appliance configured for attachment to the
bone fasteners, the prosthedontic appliance comprising: an aperture
for receiving one of the bone fasteners; wherein the aperture is
configured to allow the upper portion of the head of one of the
bone fasteners to pass therethrough so that the aperture is
positioned within the groove to secure the prosthodontic device to
the bone fastener.
2. The medical apparatus of claim 1, wherein the upper portion of
the head of each bone fastener is contoured to allow the upper
portion to pass through the aperture of one of the attachment
loops.
3. The medical apparatus of claim 2, wherein the upper portion of
the head of each bone fastener includes a beveled edge to allow the
upper portion to pass through the aperture of one of the attachment
loops.
4. The medical apparatus of claim 2, wherein the aperture of each
attachment includes a beveled edge to allow the upper portion of
one of the bone fasteners to pass therethrough.
5. The medical apparatus of claim 2, wherein the upper portion of
the head of each bone fastener is rounded to allow the upper
portion to pass through the aperture of one of the attachment
loops.
6. The medical apparatus of claim 1, wherein the head of each bone
fastener includes a drive mechanism for engagement by a tool for
attaching the bone fastener; and wherein the shaft of each bone
fastener is threaded.
7. The medical apparatus of claim 1, wherein the aperture has a
minimum dimension, wherein a minimum dimension of the upper portion
of each bone fastener is greater than the minimum dimension of the
aperture, and wherein a minimum dimension of the lower portion of
each bone fastener is greater than the minimum dimension of the
aperture.
8. A medical apparatus comprising: a plurality of bone fasteners
configured for attachment to a mandible, a maxilla, a bone graft
thereof, or a prosthodontic jaw portion of the subject, each bone
fastener comprising: a head having an upper portion separated from
a lower portion by a groove, and a shaft extending from the lower
portion; a prosthedontic appliance comprising: a plurality of
attachment tabs, each attachment tab including a first portion and
a second portion divided by a slot, wherein the two portions define
an aperture and are configured for limited movement relative to one
another; wherein each attachment tab is configured to allow the
head of one of the bone fasteners to pass through the slot to the
aperture so that the the first portion and the second portion are
positioned within the groove to secure the attachment tab to the
bone fastener.
9. The medical apparatus of claim 8, wherein the head of each bone
fastener includes a drive mechanism for engagement by a tool for
attaching the bone fastener; and wherein the shaft of each bone
fastener is threaded.
10-23. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of and priority to U.S.
Provisional Application No. 62/319,691, filed on Apr. 7, 2016, and
U.S. Provisional Application No. 62/253,802, filed on Nov. 11,
2015. The contents of each application are incorporated herein by
reference in their entirety.
FIELD
[0002] The invention is generally related to maxillofacial/dental
devices. More specifically, the invention is related to devices for
the maxillary and/or mandibular fixation or stabilization.
[0003] The fixation or stabilization of the upper and lower dental
occlusal arches to one another is known as intermaxillary fixation
(IMF), also known as maxillo-mandibular fixation (MMF). IMF has
historically been a necessity in the treatment of all
reconstructive jaw procedures.
BACKGROUND
[0004] The fixation or stabilization of the upper and lower dental
occlusal arches to one another is known as intermaxillary fixation
(IMF), also known as maxillo-mandibular fixation (MMF). IMF has
historically been a necessity in the treatment of all
reconstructive jaw procedures.
[0005] The earliest methods for providing IMF consisted of wiring
techniques, in which metallic wires were placed around one or more
(adjacent) teeth at their base(s) and were then twisted down to the
teeth in a secure manner. When a wire is passed around a tooth (or
teeth) at the base in such a way, it may be termed a circumdental
wire ligature (CW). Multiple CW's can be placed along the span of
the dental arch in a series, or the wire may also be fashioned such
that a single continuous strand incorporates multiple teeth along
the arch securely. In whatever manner this is accomplished, both
upper and lower arches are so treated, and subsequently the jaws
are then secured to one another with wire loops or elastics
incorporating single or multiple CW or the opposing jaws, thus
accomplishing IMF.
[0006] Arch bars (or arch wires) are known to those of skill in the
art. Arch bars involve the use of a linear metal bar or wire that
may be applied and secured to the dental arch form. Arch bars
typically have a plurality of hooks/tabs facing in a single
direction. The arch bars and their corresponding hooks are placed
in opposing directions for the upper and lower jaws so that wire
loops or elastics could securely affix the jaws together. Multiple
types of arch bar have been proposed. Arch bars have the advantage
of stability. The relatively rigid bar spanning along the dental
arch provides stability along the upper border of either jaw even
when a fracture is present between teeth. A plurality of hooks
allows placement of elastics or wire loops between the jaws at
varying angles to potentially affect varying, advantageous tension
vectors. Two common methods of securing arch bars are (1) via
circumdental wire ligatures, placed around the teeth in routine
fashion but incorporating the arch bar; and (2) via orthodontic
adhesives of a variety of types.
[0007] However, both of these methods suffer drawbacks. For
example, the most common means to secure arch bars is via multiple
circumdental wire ligatures. This is a time-consuming process,
associated with significant discomfort and potential for dental
injury. The wire ligatures themselves are uncomfortable and often
must be adjusted/tightened by the treating physician. Removal of
arch bars applied using CW's, is equally uncomfortable; there is
further associated potential for dental injury; in some, removal
requires operative anesthesia.
[0008] While orthodontic adhesives are known, they too have
disadvantages, in large part due to the conditions under which IMF
is performed. For example, IMF is often performed by a surgical
specialist, who is unfamiliar with the techniques and procedures
used by orthodontists and dentists in the area of dental adhesives.
The procedures are also, many times, conducted in a trauma setting
where damage and blood loss limit the ability to work with such
adhesives--which require a relatively clean, dry field for
efficacy.
[0009] Adhesive techniques and circumdental wiring techniques both
require adequate dentition. Both techniques may be severely limited
or even precluded in conditions for dental injury, loss, or
preexisting poor dental health.
[0010] Another method of IMF is also known by utilizing individual
screws, placed in the bone between tooth roots, with a portion of
the screw projecting external to the gingival or mucosa. Two or
more IMF screws are typically placed into each of the upper and
lower jaws. A wire loop is then either wrapped around the exposed
portion of two opposing screws, or through a hole that is drilled
through each of the two opposing screw heads, to provide IMF.
[0011] The advantages of IMF screw fixation are speed of placement
and comfort. The screws rarely require adjustment, are
well-tolerated, and are easily removed. However, IMF screws do not
provide stability along the dental arch as does an arch bar.
Ideally, IMF is used not only for immobilization, but also for
accurate restoration of occlusion. For fractures occurring between
teeth, IMF screws do not provide upper border stabilization nor
flexible technical application methods to optimize occlusion.
Finally, it is difficult (if not impossible) to apply elastics
between IMF screws. Elastic IMF is safer than wiring the jaws
together, and is often preferred for specific fracture types in
which the surgeon would prefer the patient to have guided mobility
of the jaws rather than relative immobilization.
[0012] Most of the technologies proposed for IMF technologies to
date have been developed by orthodontists and oral surgeons. These
dental specialists have been understandably inclined to consider
only methods which involve fixation to teeth, a concept that has
been historically accepted and perpetuated since the early 1900's.
The most significant developments in reconstructive jaw surgery in
the modern era have focused largely on methods for internal
fixation (plating), rather than IMF. However, internal fixation is
not a replacement for IMF, nor does is preclude the need for IMF in
most cases, which is still a mandatory procedure for reconstruction
of the dental arches.
[0013] Despite developments in dental arch fixation technology, and
advanced developments in other dental areas, the need to improve
how to anchor arch bars to bone remains.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is a frontal view of an arch bar prior to bending to
approximate the shape of a mandible or a maxilla, according to one
embodiment.
[0015] FIG. 2 is a top view of an arch bar bent into a shape to
approximate a maxillary or mandibular arch, according to one
embodiment.
[0016] FIG. 3 is a perspective view of an arch bar fastener,
according to one embodiment.
[0017] FIG. 4A is a perspective view of the arch bar fastener of
FIG. 3 and an attachment loop of an arch bar, according to one
embodiment.
[0018] FIG. 4B is a cross-section view of the arch bar fastener of
FIG. 3 coupled to and an attachment loop of an arch bar, according
to one embodiment.
[0019] FIG. 5 is a perspective view of an arch bar fastener,
according to another embodiment.
[0020] FIG. 6 is a perspective view of the arch bar fastener of
FIG. 3 and an attachment loop of an arch bar, according to another
embodiment.
[0021] FIG. 7 is frontal view of an arch bar prior to bending to
approximate the shape of a mandible or a maxilla, according to
another embodiment.
[0022] FIG. 8 is a perspective view of an arch bar fastener and an
elongated stem of an arch bar, according to one embodiment.
[0023] FIG. 9 is a perspective view of an arch bar fastener coupled
to an elongated stem of an arch bar, according to one
embodiment.
[0024] FIG. 10 is a cross-section view of an arch bar fastener
coupled to an elongated stem of an arch bar, according to another
embodiment.
[0025] FIG. 11 is detail frontal view of an elongated stem of an
arch bar, according to one embodiment.
[0026] FIG. 12 is a side view of a hook, with cross-section of the
bar, according to one embodiment.
[0027] FIG. 13 is a panoramic view of a full dental arch having a
first and second arch bar in place across the dentition, according
to one embodiment.
[0028] FIG. 14 is a perspective view of a screw, according to one
embodiment.
[0029] FIG. 15 is a side view of a portion of an arch bar,
according to one embodiment.
[0030] FIGS. 16A-16C are sectional views along line 16 of the arch
bar of FIG. 15, according to exemplary embodiments.
[0031] FIG. 17 is a perspective view of the screw of FIG. 14 and
the arch bar of FIG. 15.
[0032] FIG. 18 is a perspective view of a screw, according to one
embodiment.
[0033] FIG. 19 is a side view of a portion of an arch bar,
according to one embodiment.
[0034] FIG. 20 is a perspective view of the screw of FIG. 18 and
the arch bar of FIG. 19.
[0035] FIG. 21 is a side view of a portion of an arch bar,
according to one embodiment.
[0036] FIG. 22 is a perspective view of a screw, according to one
embodiment.
[0037] FIG. 23 is a perspective view of a screw, according to one
embodiment.
[0038] FIG. 24 is a perspective view of the screw of FIG. 23 and an
arch bar.
[0039] FIG. 25 is a schematic view of a stem insertion and wrapping
path, according to one embodiment.
[0040] FIG. 26 is a side view of an arch bar, according to one
embodiment.
[0041] FIG. 27 is a side view of a portion of the arch bar of FIG.
26.
[0042] FIG. 28 is a perspective view of a screw and the arch bar of
FIG. 26.
DETAILED DESCRIPTION
[0043] Arch bars are described for providing stabilization and/or
fixation between the mandible and maxilla using device(s) affixed
to bone (native or graft) or prosthedontic appliances for use in
applications including, but not limited to, treatment of fracture,
restoration and fixation of dental occlusion, and maxillary and/or
mandibular reconstruction with or without bone grafts. The arch
bars may be affixed to bone via bone fasteners (e.g., screws) or
the use of adhesives), thus precluding the need for CW.
[0044] According to an exemplary embodiment, the bone fasteners are
attached to the maxilla or the mandible of the subject,
independently as a first step, before the subsequent attachment of
the arch bar to the bone fasteners. This allows for an easier and
more accurate placement of the bone fasteners than the conventional
approach of simultaneously attaching each arch bar fastener to the
arch bar and the maxilla or mandible (e.g., by inserting the arch
bar fastener through an attachment loop and screwing the fastener
into the maxilla or mandible). By separating the two attaching
functions (i.e., attaching the bone fasteners to the maxilla or
mandible and attaching the bone fasteners to the arch bar), it is
easier for a surgeon to position the bone fasteners as needed
(e.g., between tooth roots) by not also requiring that the fastener
be attached to the arch bar while it is being attached to the
maxilla or mandible.
[0045] As shown in FIG. 1, and according to one embodiment, an arch
bar 100 is a bar 110 having a first attachment loop 120a, a second
attachment loop 120b, and a plurality of hooks 130. The first
attachment loop 120a is distally located to the second attachment
loop 120b such that each end of the bar, may be secured to a bone
such a mandible or maxilla, or a prosthedontic apparatus via the
first and second attachment loops 120a, 120b. The attachment loops
120a, 120b may be attached to the bar 110 via a stem 140a or 140b
that is rigid or bendable. In some embodiments, a portion of the
stem 140 may be rigid or semi-rigid while the remainder of the stem
140 is flexible. The stem 140 may have a variety of cross-sectional
shapes (e.g., rectangular, circular, oval, etc.). The bar 110 may
be bendable to approximate a maxillary or mandibular arch, for
example as shown in FIG. 2.
[0046] As used herein, the term "bendable" is to mean that the item
to which the term refers may be moved, or shaped, in response to
the application of an external force. Further, once moved or bent,
the item does not return to its previous position, without being
acted upon by a second external force. In other words, the item is
bent and stays bent, until bent into another shape or position.
[0047] As used herein, the term "rigid" is used to refer to an item
that resists bending to a moderate force, but may be bent under
extreme force as compared to a bendable item.
[0048] The bar may be made from a variety of materials known to
those of skill in the art. For example the bar may be made from
stainless steel, titanium, or other metals; acrylics; and/or
polymers.
[0049] In some embodiments, the bar 110 has one or more additional
attachment loops 120c, 120d located between the first 120a and
second 120b attachment loops. For example, the bar 110 may have a
third attachment loop 120c located approximately midway between the
first 120a and second 120b attachment loops, thereby providing an
additional point of attachment for the bar.
[0050] The attachment loops 120 provide a point at which the bar
110 may be secured to a maxilla, a mandible, or a prosthetic
appliance using a screw, a bone screw, or other fastener known to
those of skill in the art. In some embodiment, the one or more
additional attachment loops refers to a third, a fourth, a fifth, a
sixth, a seventh, or more attachment loops that are even spaced
along a length of the bar 110, or at other predetermined
positions.
[0051] The attachment loops 120 may be integrally formed with the
bar 110 as if a single piece of material were used and each portion
cut or formed from the single piece. In other embodiments, the
attachment loops 120 are made from a separate piece of material and
attached to the bar 110 via welding, adhesive, rivets, screws, or
via other attachments known to those of skill in the art. The
material from which the attachment loops 120 may be made may be the
same as the bar 110, or of a different material.
[0052] The attachment loops 120 may be appended from the arch bar
100 via a stem 140 that is bendable. A bendable stem provides for
the individual adjustment of each attachment loop to a position
that allows for insertion of a screw into bone and between the
roots of adjacent teeth, or for other adjustment of the position as
desired by the surgeon or other medical professional.
[0053] A variety of fasteners may be used to attach the bar 110 to
a maxilla or a mandible. For example, such fasteners may include
screws, rivets, bolts, staples, or other fastener known to those of
skill in the art. The fasteners are attached to the maxilla or
mandible via a variety of systems. For example, a hole for
attaching the fastener may be pre-drilled in the maxilla or
mandible, or the fastener may be a self-drilling or self-tapping
fastener. The size of the fastener may also be varied depending
upon the placement desired. For example, mandibles are typically
thicker than maxillas and therefore a mandible is capable of
receiving a longer and/or wider fastener than the maxilla.
Fasteners may also be flush mounted to the gingiva or may have a
relief from the gingival surface so that there is some amount of
externalization for a surgeon or dental professional to easily find
the fastener when removal of the device is desired.
[0054] FIG. 3 shows a bone fastener 300 according to an exemplary
embodiment. The bone fastener 300 is shown as a bone screw having a
threaded shaft 310, a tip 320, and a head 330. The bone screw may
be inserted into a bone such as a maxilla or mandible via a pilot
hole that was previously drilled, or the tip and shaft may be
configured to be self-drilling or self-tapping.
[0055] The head 330 of the bone fastener 300 may have a slotted
drive mechanism 335 for engaging a slotted screwdriver to drive the
bone fastener 300 into bone. The slotted drive mechanism 335 is
shown only as an example, as alternatively the drive mechanism may
be able to be engaged by a Phillips driver, a star driver, an Allen
wrench, or other driver, wrench, or tool known to those of skill in
the art. Alternatively, the head 330 may be shaped as a hex-head or
any shape known to those of skill in the art for engaging a driver
for the screw.
[0056] The head 330 includes a circumferential groove 340 (e.g.,
indentation, recess, slot, etc.) configured to receive one of the
attachment loops 120. The groove 340 is formed by a support 342
that separates an upper portion 350 of the head 330 from a lower
portion 360. The upper portion 350 and the lower portion 360 each
have a width 355 that is greater than the minimum dimension 365
(e.g., diameter) of the openings 370 in the attachment loops 120.
In another embodiment, the arch bar 110 may be coupled to one or
more bone fasteners 300 by an elongated slot formed in the arch bar
110, where the minimum dimension (e.g., width) of the slot is less
than the width 355.
[0057] The screw may project through the gingiva or mucosa for ease
in removal, or it may be designed to sit flush with the bone. To
secure the arch bar to the maxilla or the mandible, insertion of
the bone fasteners 300 into a root should be avoided. In fact, it
is desired that the bone fasteners 300 are inserted into the bone
at positions between the roots of adjacent teeth. After the bone
fasteners 300 have been inserted into the bone, the attachment
loops 120 of the arch bar 100 is coupled to the bone fasteners
300.
[0058] FIGS. 4A-4B show the attachment loop 120 coupled to the bone
fastener 300. According to an exemplary embodiment, the upper
portion 350 may include a beveled edge 380. The bottom face of the
attachment loop 120 may include a beveled edge 390 surrounding the
opening 370. The attachment loop 120 is pressed onto the bone
fastener 300 and the upper portion 350 is forced through the
opening 370. The attachment loop 120 is therefore trapped in the
groove 340, between the upper portion 350 and the lower portion 260
of the head 330 to attach or secure the attachment loop 120 to the
fastener. The beveled edges 380 and 390 provided ramped surfaces to
facilitate the insertion of the upper portion 350 through the
opening 370, coupling the attachment loop 120 to the bone fastener
300 without the use of an additional fastening device.
[0059] In some embodiments, the attachment loop 120 and/or the bone
fastener 300 may be formed from an alloy or other material with a
modulus of elasticity that allows sufficient deformation between
the components to allow the upper portion 350 to pass through the
opening 370 without the application of an excessive force (e.g.,
one that would injure or cause excessive discomfort to the
subject). That is, the attachment loop 120 and/or the bone fastener
300 deform so that a person may attach or secure the arch bar 100
to the bone fasteners 300 by "snapping" the attachment loop 120
onto the bone fasteners 300 by hand.
[0060] The shape of the head 330 as shown in FIGS. 3-4B is
exemplary only. In other embodiments, the head 330 may be otherwise
shaped to have an upper portion with a first width that is greater
than the opening 370 in the loop 120 and portion with a lesser
width configured to receive the loop 120. As shown in FIGS. 3-4B,
the head 330 may be a relatively low profile head. In other
embodiments, the head 330 may have a higher profile with a more
conical shape. In other embodiments, the head 330 may be otherwise
shaped. For example, as shown in FIG. 5, the head 330 may be formed
with a round upper portion 550 and a groove 540 separating the
round upper portion 550 from a lower portion 560.
[0061] In other embodiments, the loop 120 may be otherwise coupled
to the head of the bone fastener 300. As shown in FIG. 6, a loop
620 may be an open loop that is configured to be received by the
groove 340 of the head 330 of a bone fastener 300 from the side
rather than over the top of the head 330. A slot 673 extends
through the loop 620 to the aperture 670, dividing the loop 620
into two portions, 675 and 677. The two portions 675 and 677 are
movable relative to one another by a limited amount that is at
least sufficient to allow the head 330 of the bone fastener 300 to
pass though the slot 673 to the aperture 670. As illustrated, the
support 342 of the head 330 is wider than the slot 673 and passing
the support 342 through the slot 673 cause the two portions 675 and
677 of the loop 620 to move relative to one another to all allow
the support 342 to move into the aperture 670, thereby positioning
the loop 620 within the groove 340 to attach or secure the loop 620
to the bone fastener 300. Additionally, the portions 675 and 677
may be crimped, wrapped about one another, or otherwise secured to
one another to help secure the loop 620 to the bone fastener
300.
[0062] In still other embodiments, the arch bar 100 may be
otherwise coupled to the bone fastener 300. For example, as shown
in FIGS. 7-11, arch bar 100 may not include loops but may instead
be coupled to the bone fasteners 300 with flexible elongated stems
740 (e.g., tabs, bars, protrusions, etc.) that are bent or wrapped
about a portion of the bone fastener 300. Bending or wrapping the
stem 740 about a portion of the bone fastener 300 includes
situations where the stem 740 is bent or wrapped about the fastener
for less than one revolution, for one revolution, and for more than
one full revolution. The stems 740 are configured to be relatively
flexible to facilitate being bent or wrapped about the bone
fastener 300. The stems 740 may, for example be formed from a
relatively flexible alloy, or may be treated (e.g., annealed) to
increase flexibility. The stems 740 may be solid with various cross
sectional shapes (e.g., rectangular, circular, oval, etc.) or may
be formed from several smaller stands (e.g., braided or twisted
strands).
[0063] As shown in FIG. 8, in one embodiment, the stem 740 is
inserted into a through hole 800 formed in the support 342 of the
head 330 of the bone fastener 300. The stem 740 may then be wrapped
about the head 330 of the bone fastener 300. The stem 740 and/or
the head 330 may be contoured or textured to inhibit the relative
motion between the stem 740 and the bone fastener 300 in one or
more directions. For example, the stem 740 and/or the head 330 may
be formed with a ratchet mechanism allowing the stem 740 to be
inserted into the hole 800 but inhibiting the removal of the stem
740 from the hole 800. A set mark 810 may be provided on the
surface of the stem 740 to indicate the amount of the stem 740 to
be inserted into the hole 800 to achieve a preferred position of
the arch bar 110 relative to the bone fastener 300. In some
embodiments, the stem 740 may include multiple set marks. A stop
745 may be provided to limit the insertion of the stem 740 into the
hole 800.
[0064] The stem 740 may be wrapped around the head 330, as shown in
FIG. 9 (e.g., about the support 342 and within the groove 340). In
other embodiments, the stem 740 may be wrapped vertically around
the head 330 (e.g., around the upper portion 350), or any other
direction around the head 330 to prevent the stem 740 from being
withdrawn back through the hole 800. The stem 740 may be otherwise
fixed in relation to the bone fastener 300 after passing through
the hole 750. For example, a stopper 1000 may be coupled to the
stem 740 on either side of the hole 800 to prevent the stem 740
from being withdrawn back through the hole 800, as shown
schematically in FIG. 10. The stopper 1000 may be a separately
applied fixation clip. In another embodiment, the stem 740 may be
crimped or otherwise deformed on either side of the hole 800 to
prevent the stem 740 from being withdrawn back through the hole
800.
[0065] In other embodiments, the stem 740 may not pass through a
through hole in the head 330 but may instead simply be wrapped
around the head 330 (e.g., wrapped around the groove 340). The head
may include outwardly extending features (e.g., arms) around which
the stem 740 may be wrapped.
[0066] Referring now to FIG. 11, in some embodiments, the stem 740
may have varied physical properties along its length. For example,
The stem 740 may include a first portion 1100 proximal to the bar
110 that is relatively stiff or semi-rigid and a second portion
1110 distal to the bar 110 that is relatively flexible. In one
embodiment, the first portion 1100 has a width that is greater than
the width of the second portion 1110. The set mark 810 may, in some
embodiments, be disposed at the border between the first portion
1100 and the second portion 1110.
[0067] In some embodiments, the base of the head of the bone
fastener 300 (e.g., the lower portion 360) is of a larger diameter
than a shaft of the bone fastener 300 to permit solid coaptation
(via surface area contact) of the arch bar to the bone, much like a
washer. Wire or elastics may then be placed between the arch bar
opposing hooks 130, or tabs, therefore a passage hole through the
screw is not required, as was common with IMF screw fixation.
[0068] As noted above, a plurality of hooks 130 are attached to the
bar 110. As used herein, plurality may mean one, but typically
means more than one, such as two, three, four, five, six, seven,
eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen,
sixteen, seventeen, eighteen, nineteen, or twenty. The hooks 130
are used to attach a wire, an elastic such as a rubber band, or
other device known to those of skill in the art, to the bar 110 to
immobilize, stabilize, or fixate the maxilla to the mandible, thus
allowing for healing of the respective bones.
[0069] As depicted in FIG. 12, the hooks 130 may have the open part
of the hook in a position opposed to the attachment loop. However,
in other embodiments, the hook may have the open part of the hook
turned toward the attachment loop. In such other embodiments, the
attachment loops and hooks may be staggered in position so that the
hook does not interfere with attaching the attachment loop to the
bone fastener. The size, shape, and configuration of the hooks may
vary according to design preferences. The common mandatory design
element is the ability to satisfactorily allow placement of wire,
elastic, or other fasteners.
[0070] In some aspects, the medical apparatus has two arch bars, as
shown in FIG. 13. A first arch bar 1300 is attached to the maxilla
and a second arch bar 1400 is attached to a mandible. The bars
1310, 1410 are attached to bone fasteners 300 that have previously
been attached to the maxilla and mandible. The hooks 1330, 1430 on
each of the arch bars 1300, 1400 opposed to one another so that the
securing wires 1380, elastics such as rubber bands, or other
attachment devices can be hooked to the arch bars 1300, 1400 on the
maxilla and mandible. The securing wires 1380 or other attachment
devices may be separate entities as shown in FIG. 13, or a single
wire may be intricately woven to attach arch bar 1300 to arch bar
1400, thus fixating the maxilla and/or mandible.
[0071] Referring to FIG. 14, a bone fastener 300 is illustrated
according to an exemplary embodiment. The bone faster 300 includes
a Phillips-head drive mechanism 335. Referring to FIG. 15, a
portion of an arch bar 100 is illustrated according to an exemplary
embodiment. The stem 740 includes a stop located near the bar 100
to limit insertion of the stem 740 into the hole 800 of the screw
300. FIGS. 16A, 16B, and 16C show exemplary cross sections of the
stem 740. In some embodiments, the shape of the hole 800 of the
screw 300 matches the particular cross section of the stem 740.
Referring to FIG. 17, an exemplary method of securing the screw 300
to the bar 100 via the stem 740 is illustrated. As shown by the
arrows, the stem 740 is first inserted through the hole 800 of the
screw 300 and then wrapped around the screw 300 in the groove
340.
[0072] Referring to FIG. 18, a bone fastener 300 is illustrated
according to an exemplary embodiment. The illustrated bone fastener
300 is similar to the bone fastener illustrated in FIG. 14, except
that it does not include a hole 800 and instead only includes the
groove 340 for securing the bone fastener to a stem of an arch bar.
Referring to FIG. 20, an alternative stem 740 having an open-loop
arrangement including two arms 746 and 747 is illustrated according
to an exemplary embodiment. The two arms 746 and 747 extend in
opposite directions from a central location. The arms 746 and 747
are flexible. Referring to FIG. 19, an exemplary method of securing
the screw 300 to the bar 100 via the stem 740 is illustrated. As
shown by the arrows, each arm 746 and 747 is wrapped around the
screw 300 in the groove 340, with the arms 746 and 747 being
wrapped around the screw 300 in opposite directions (e.g.,
clockwise and counterclockwise). Referring to FIG. 21, a pliers 748
or other crimping tool may be used to secure the stem 740 having
the two arms 746 and 747.
[0073] Referring to FIG. 22, a bone fastener 300 is illustrated
according to an exemplary embodiment. The illustrated bone fastener
300 is similar to the bone fastener illustrated in FIG. 14, except
that the groove 340 is taller and includes a top portion 815 that
includes the hole 800 and a bottom portion 820 that does not
include the hole. The taller groove 340 provides increased surface
area for wrapping the stem 740 around the screw 300, which may help
to better secure the screw 300 to the arch bar 100. Referring to
FIG. 23, a bone fastener 300 is illustrated according to an
exemplary embodiment. The illustrated bone fastener 300 is similar
to the bone fastener illustrated in FIG. 23, except that the hole
800 is located in the bottom portion 820 of the groove, not the top
portion 815. Referring to FIG. 24, an exemplary method of securing
the screw 300 to the bar 100 via the stem 740 is illustrated. As
shown by the arrow in FIG. 25, the stem 740 is first inserted
through the hole 800 of the screw 300 and then wrapped around the
screw 300 in the upper portion 815 of the groove 340. FIGS. 22-25
illustrate a screw 300 including a pass-through channel 800 (i.e.
through-hole variation) with sufficient space beneath the hold to
bend the stems 740 (i.e. elongated extensions from the arch bar
such as tabs, wires, flanges, etc.) around, above, or below the
pass-through channel 800. The stems 740 are located close to one
another to allow for selection of the appropriate stem 740 for
attachment to the previously placed screw 300. In some embodiments,
the stems 740 have a wire-sized gauge (e.g. 15-20 gauge). In some
embodiments, there is sufficient room in the gap 340 of the screw
300 to accommodate one or more wraps of the stem 740 around the
screw 300. In other embodiments, there is sufficient room in the
gap 340 of the screw 300 to accommodate two or more wraps of the
stem 740 around the screw 700. In yet other embodiments, the stem
740 may be wrapped, or passed back under itself.
[0074] Referring to FIG. 26, an arch bar 100 is illustrated
according to an exemplary embodiment. The stems 740 include a
number of ridges and grooves 810 (e.g., serrations) that interact
with a stopper or fastener 1000 (FIG. 28) to secure the screw 300
to the arch bar 100. The ridges and grooves 810 and the stopper
1000 may interact in the manner of a zip-tie that allow the stopper
1000 to be slid onto the stem 740 in a first direction and prevent
removal of the stopper 1000 from the stem 740 in an opposite
direction. FIG. 27 illustrates an exemplary embodiment of a stem
740 including a stop 745 for limiting inserting of the stem 740
into a hole 800 of a screw 300. In some embodiments, the length the
stem 740 extends from the bar 100 is no more than 3 centimeters.
Referring to FIG. 28, an exemplary method of securing the screw 300
to the bar 100 via the stem 740 is illustrated. As shown by the
arrow, the stopper 1000 is slid onto the stem 740 to secure the
stem 740 to the screw 300 after the stem has been inserted into the
hole 800 of the screw 300. The stem 740 has a stop 745 on an arch
bar 100 inserted into the pass-through channel 800 of a screw 300,
according to one embodiment, where the serrations 810 may then be
engaged by a locking feature 1000 that slides over the stems 740
and engages the serrations 810, or the serrations 810 may be
engaged within a head of the screw 300 without the use of the
locking feature 1000. In one embodiment, the screws 300 are placed
in to the mandible or maxilla of a subject, the stems or tabs 740
of the arch bar 100 are then aligned with the pass-through channels
800 of the screws 300 and inserted therein. The positioning of the
arch bar 100 is then adjusted if needed. Where the serrations 810
on the stems 470 are not engaged by counter serrations in the head
of the screw 300, the locking feature 1000 is then slid over the
stem 740 and the excess stem length is cut off.
[0075] In another aspect, methods are provided for stabilizing a
mandibular arch or a maxillary arch using the medical apparatuses
described above. For example, the arch bar may be bent to
approximate the mandibular arch or the maxillary arch of a patient
in need of stabilization or fixation of the mandibular and/or
maxillary arch. Screws or bone fasteners are attached or secured in
the mandible and/or maxilla and the arch bar is then attached to
the screws.
[0076] In other embodiments, where both a mandibular and a
maxillary arch bar are used, the methods also include securing a
wire, an elastic, or other flexible or semi-rigid material between
the hooks of the mandibular arch bar and the hooks of the maxillary
arch bar. This may be done to establish intermaxillary fixation or
dental occlusion. Such methods are known as wiring the jaws shut or
intermaxillary fixation. The securing device used to fasten or
secure the two arch bars to one another may also further secure
each arch bar to the bone fasteners as the tension in the securing
device pulls the two arch bars toward one another and against the
bone fasteners.
[0077] The above described apparatuses and methods are used to
restore, fixate, or create a new dental occlusion between existing
native dentition, dental implants, or other dental appliances, or
for the treatment of fracture and/or reconstructing maxillary
and/or mandibular reconstruction.
[0078] The embodiments illustratively described herein may suitably
be practiced in the absence of any element or elements, limitation
or limitations, not specifically disclosed herein. Thus, for
example, the terms "comprising," "including," "containing," etc.
shall be read expansively and without limitation. Additionally, the
terms and expressions employed herein have been used as terms of
description and not of limitation, and there is no intention in the
use of such terms and expressions of excluding any equivalents of
the features shown and described or portions thereof, but it is
recognized that various modifications are possible within the scope
of the invention claimed. Additionally the phrase "consisting
essentially of" will be understood to include those elements
specifically recited and those additional elements that do not
materially affect the basic and novel characteristics of the
claimed invention. The phrase "consisting of" excludes any element
not specifically specified.
[0079] One skilled in the art will readily realize that all ranges
discussed can and do necessarily also describe all subranges
therein for all purposes and that all such subranges also form part
and parcel of this invention. Any listed range can be easily
recognized as sufficiently describing and enabling the same range
being broken down into at least equal halves, thirds, quarters,
fifths, tenths, etc. As a non-limiting example, each range
discussed herein can be readily broken down into a lower third,
middle third and upper third, etc.
[0080] All publications, patent applications, issued patents, and
other documents referred to in this specification are herein
incorporated by reference as if each individual publication, patent
application, issued patent, or other document was specifically and
individually indicated to be incorporated by reference in its
entirety. Definitions that are contained in text incorporated by
reference are excluded to the extent that they contradict
definitions in this disclosure.
[0081] The present invention, thus generally described, it should
be understood that changes and modifications can be made therein in
accordance with ordinary skill in the art without departing from
the invention in its broader aspects as defined in the following
claims.
* * * * *